REVISION Hip Neck ReamerRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033390112635), received between Dec 2, 2025 and Jan 19, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Degraded” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 19, 2026Mechanical Problem; Dull, Blunt

  DURING HIP REVISION SURGERY PERFORMED ON (B)(6) 2026 WHILE UTILIZING THE REVISION - NECK REAMER (PRODUCT CODE 9038.10.620, LOT NUMBER NOT PROVIDED), THE SURGEON WAS UNABLE TO SUFFICIENTLY REAM AS INTENDED WITHOUT PUTTING SIGNIFICANT FORCE THROUGH THE REAMER AND CLEARING OUT THE SURROUNDING BONE WITH LARGER STEM REAMERS DUE TO HOW BLUNT THE INSTRUMENT WAS. PROLONGED SURGICAL TIME (15-30 MIN) AND SURGEON HAD TO APPLY A SIGNIFICANT AMOUNT OF PRESSURE/FORCE TO UTILIZE THE ITEM WHICH COULD HAVE RESULTED IN FRACTURE AS WELL AS USE ALTERNATIVE INSTRUMENTS TO ACHIEVE THE DESIRED RESULT. PATIENT IS FEMALE, 69 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.

  Patient problems: Bone Fracture(s)

  MAUDE report 24108818 ↗
• MalfunctionDec 2, 2025Degraded; Degraded

  DURING A THA PERFORMED ON (B)(6) 2025, THE NECK REAMER (PRODUCT CODE 9038.10.620 LOT N. 16AQ0AG) WAS BLUNT IN A CONSIGNMENT SET AND CAUSED A VERY DIFFICULT REAMING, PARTICULARLY WITH HARD BONES. FOR THIS ISSUE THE SURGERY WAS DELAYED FOR MORE THAN 40 MINS. PATIENT IS 65 YEAS OLD. EVENT HAPPENED IN AUSTRALIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692499 ↗